Kornimate/medical-research-clean huggingface dataset:
quality of life among children with congenital heart disease

Conditions: Congenital Heart Disease

Summary: congenital heart diseases (chd) are the first cause of congenital malformations with an incidence of 8 for 1000 births. within the two past decades prenatal diagnosis has had a great impact on chd prevalence. france was the first country to show the impact of prenatal diagnosis on the lowering prevalence of the most severe chd, the hypoplastic left heart syndrome. since the 90's, great advances in pediatric cardiac surgery, intensive care and cardiac catheterization have led to lower mortality and morbidity in this population. prevalence of " guch ", grown-ups with congenital heart disease has thus been significantly increasing. for all these reasons and as the investigators can also see in other many chronic diseases, new questions about the quality of life of these patients arise among patients, parents/future parents, doctors, patients associations, and public health organizations. in 2007 french government promoted a national public health plan for "improvement of the quality of life among patients suffering from chronic illnesses". first step of such a program is to correctly evaluate this quality of life. indeed the concept of "quality of life" (qol) remains subjective and difficult to appreciate and measure. its analysis requires the use of validated questionnaires. few questionnaires are available in europe, especially in pediatrics. few studies in this population have been led and no comparative study to a control randomized group has been published. the investigators study aims to analyze in the investigators tertiary care center in pediatric cardiology the qol among 8 to 18 year old french patients with chd using a validated questionnaire (kidscreen™) and to compare it to same aged healthy children. the investigators secondarily intend to :- validate the french version of one reference pediatric qol questionnaire used in most publications in the usa (pedsql™). - compare the qol to the severity of the chd using a published semi-quantitative score.- compare the qol to the severity of the chd using the results of routine exercise tests (vo2 max) performed routinely in the investigators center. the investigators hypothesis are that :- quality of life of most common and not severe chd is close to that of healthy children. - qol of severe chd is not so well correlated to severity of chd.- pedsql™ is a simple questionnaire which can be used in france in routine follow-up of children with chd.


Eligibility criteria:
inclusion criteria: * patients with congenital heart disease (defined by chapter q of the icd-10) * patient participation in the study noted in the medical record.exclusion criteria: * age greater than or equal to 8 years and less than 18 years * whose parents signed written consent * obligation of membership or beneficiary of a french social security

Keywords: children with congenital heart disease
follow-up home visits with nutrition

Conditions: Malnutrition

Summary: to assess the effect on geriatric patients of follow-up home visit including nutrition. the hypothesis is that this can prevent hospital readmissions, and has a positive impact on functional abilities and quality of life

before and after the intervention the participants nutritional status, hand grip strength, functional abilities, well-being, dietary intake, level of tiredness,and activities of daily living will be assessed

Eligibility criteria:
inclusion criteria: * geriatric patients in nutritional risk exclusion criteria: * dementia * expected readmissions * terminal disease * non-danish speaking

Keywords: follow-up home visit geriatric disorder rehabilitation
cardiac resynchronisation via stimulation of the left bundle in af patients.

Conditions: Pacing-Induced Cardiomyopathy

Summary: permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. we hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing. patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled. they will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation. they will be prospectively followed during 6 months.

patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled. they will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing confirmed according to electrocardiographic parameters. atrioventricular node ablation will be performed the following day through a femoral venous approach. perioperative data and potential complications will be collected. patients will be prospectively followed during 6 months. they will have clinical examination, 12-lead ecg, and an echocardiography.

Eligibility criteria:
inclusion criteria: * permanent atrial arrhythmia * symptoms related to an insufficient rate control under optimal medical therapy exclusion criteria: * indication of prophylactic defibrillator * already implanted with a cardiac device

Keywords: left bundle branch area pacing; atrial fibrillation; atrioventricular ablation; pacing-induced cardiomyopathy
electrical inhibition (ei): a preliminary study to inhibit preterm labor and preterm birth

Conditions: Premature Birth; Premature Labor

Summary: an electrical-inhibition (ei) uterine pacemaker device similar to an electrical heart pacemaker delivers a weak electrical current to the human uterus during active preterm labor to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a preterm birth.

electrical intervention (ei) uses bipolar, constant-current (1-20 ma), square-wave pulses in 20% duty cycles. women in active preterm labor have an electrode catheter placed into the posterior fornix of the vaginal canal. the ei current is given up to 80 minutes while monitoring tocodynamometric (toco) contractions and adjunct electrohysterographic (ehg) activity while continuously monitoring maternal vital signs, fetal heart rate and electrocardiogram (fecg). the study includes a pre-ei control period (c1); the ei period, when a 10-second current burst is delivered only during a contraction; and a post-ei control period (c2). the whole study will take a maximum of two hours. the uterine toco contraction frequency and adjunct ehg electrical activity are analyzed for changes caused by ei. changes in maternal vital signs, fetal heart rate and fecg will determine ei side-effects.

Eligibility criteria:
inclusion criteria: * between 24 to 34 weeks pregnant with a singleton gestation; * in preterm labor as defined by the american college of obstetricians and gynecologists and the american academy of pediatrics,78 as follows: * persistent uterine contractions (4 every 20 minutes or 8 every 60 minutes) * and any one or more of the following: * documented cervical change * \> 1cm cervical dilatation and progressing * \> 80% cervical effacement * anticipate a normal spontaneous vaginal delivery (nsvd). * at least 18 years of age * signed a written informed consent document * willing and able to comply with study requirements exclusion criteria: * severe preeclampsia * severe abruption placenta * rupture of amniotic membranes * frank chorioamnionitis * fetal death * fetal anomaly incompatible with life * severe fetal growth restriction (efw \<5%) * mature fetal lung studies * maternal cardiac arrhythmias * a permanent cardiac pacemaker * a fetal cardiac arrhythmia * contraindication for tocolysis

Keywords: electrical inhibition preterm birth premature birth preterm labor premature labor tocolytic uterus
renal metabolism in salt-sensitive human blood pressure

Conditions: Hypertension

Summary: salt sensitive hypertension is a significant health problem worldwide and a primary modifiable risk factor for renal, cardiovascular, and cerebrovascular diseases. yet, the underlying mechanisms remain poorly understood. the proposed study determines how renal oxygenation and substrate metabolism differs between individuals with and without salt sensitivity, with the ultimate goal of identifying mechanisms, diagnostic criteria, and treatment strategies for salt sensitive hypertension.

seventy subjects will be enrolled and randomized to start either a low sodium diet (1200 mg/day) or high sodium diet (\>4200 mg/day) for two weeks. after completion of two weeks, subjects will be switched to the 'other' diet for two weeks after a one-week wash-out. during the screening visit, subject's daily sodium intake will be assessed using multiple methods and further dietary information will be collected to prepare customized low sodium meals. during low sodium diet period, subjects will be supplied with food and will be asked to keep food logs. at the end of two-week period, the study activities described below will be carried out including bold mri imaging along with imaging techniques to assess renal oxygenation levels and perfusion. during high sodium diet period, subjects will be either supplemented with sodium chloride tablets or high sodium foods to achieve a daily sodium intake above 4200 mg/day. if subjects already consume over 4200 mg/day of sodium, no changes will be made to their diet and assessment of oxygenation (bold mri) and perfusion will take place after two weeks. at the end of high sodium diet, 18 subjects will have renal vein sampling performed (this will be equally divided between salt-sensitive and salt-insensitive subjects and per subject preference as all may not want to have renal vein sampling). subjects will be classified into salt sensitive or insensitive at the end of low sodium diet period based on bp response for further data analyses.

Eligibility criteria:
inclusion criteria: * english speaking subjects * with a spectrum of bps, ranging from those with elevated bp through stage 1 htn, as defined by the 2017 acc/aha htn guidelines exclusion criteria: * non-english speakers * bp ≤120/80 \& ≥ 140/90 mmhg * h/o diabetes, congestive heart failure, cirrhosis of the liver, hypokalemia \& other * electrolyte disturbances * h/o kidney disease * use of glucocorticoids * pregnant or nursing mothers * presence of bleeding disorders * use of anti-platelet and anticoagulant agents such as clopidogrel, aspirin, dabigatran, rivaroxaban etc * daily sodium intake ≥ 6000 mg/day * presence of pacemaker or other metallic implants * allergy to iodinated contrast * allergy to shellfish * claustrophobia

Keywords: hypertension high blood pressure salt
gastric cleansing by intravenous azithromycin in urgent endoscopy

Conditions: Upper Gastrointestinal Bleeding

Summary: this study will test the hypothesis that azythromycin is efficient and safe in cleansing the upper gastrointestinal tract for endoscopic examination in the case of acute bleeding.

in this study patients with upper gi bleeding will be randomzied to either i.v. azythromycin or placebo in order to evaluate the efficiency and safety of azythromycin for upper gi cleanliness during diagnostic endoscopy. a validated upper gi cleanliness score (toronto score with values up to 10) and a visual analog scale will be used to evaluate cleanliness. need for repeat endoscopy due to poor preparation, duration of hospitalization and requirement for blood transfusions during hospitalization will also be assessed. adverse venets due to medication will also be recorded carefully.

Eligibility criteria:
inclusion criteria: * acute upper gi bleeding (\<12 hours) exclusion criteria: * prokinetics \<12 hours * allergy to azithromycin * use of contraindicated drugs (due to interactions) * pregnancy * physician option
malnutrition screening and dietary intervention to improve nutrition outcomes in patients with unresectable pancreatic cancer

Conditions: Stage III Pancreatic Cancer; Pancreatic Adenocarcinoma Non-resectable

Summary: this clinical trial compares the effect of malnutrition screening and dietary intervention to standard nutrition care on patients with pancreatic cancer that cannot be removed by surgery (unresectable). fewer than 20% of patients diagnosed with unresectable pancreatic cancer do not survive one year after diagnosis so treatment often focuses on improving quality of life. many patients experience increasing pain, nausea, vomiting, loss of appetite, weight loss and weakness. behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. screening for inadequate nutrition (malnutrition) and providing weekly nutritional support may be effective methods to improve nutritional status and improve overall quality of life for patients with unresectable pancreatic cancer.

primary objectives: i. to compare the quality of life of subjects after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care. ii. to compare the frequency of hospitalization and length of stay (los) after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care. iii. to compare the subject's functional status, body weight and dietary intake after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care. outline: patients are randomized to 1 of 2 arms. arm i: patients receive standard nutrition care and record dietary intake and physical activity using myfitness pal smartphone application on study. arm ii: patients undergo malnutrition screening with a registered dietician at baseline and participate in 12 weekly nutrition support sessions and those at moderate to high risk for malnutrition receive a personalized diet prescription on study. patients also record dietary intake and physical activity using myfitness pal smartphone application on study.

Eligibility criteria:
inclusion criteria: * unresectable pancreatic adenocarcinoma, receiving either 1) no chemotherapy, 2) 1st cycle of chemotherapy, or 3) greater than 1 cycle of chemotherapy if the patient's prognosis is greater than 6 months as determined by oncology collaborators * life expectancy of greater than 3 months and a karnofsky performance score of 60 or more * adults \>= 18 years old male or female exclusion criteria: * ascites requiring paracentesis for symptom improvement * aspartate aminotransferase (ast) or alanine aminotransferase (alt) values greater than 5 times the upper limit of normal * creatinine value greater than 2.0 for men and 1.5 for women * uncontrolled pain * uncontrolled nausea and vomiting
the association between urinary incontinence, physical performance, physical activity levels in women with low back pain

Conditions: Low Back Pain; Physical Inactivity; Urinary Incontinence

Summary: the study is searching for the correlation between low back pain(lbp), physical performance, urinary incontinence and physical activity levels in women. lower physical performance, more frequent urinary incontinence and less physical activity are expected in women who have lbp.


Eligibility criteria:
inclusion criteria for healthy group: * 30-65 years women * agreeing to involve in the study inclusion criteria for women with low back pain group: * 30-65 years women * having low back pain for at least 3 months * scoring pain at least 1 in visual analog scale(vas) * agreeing to involve in the study exclusion criteria: * any kind of surgery history in low back area * surgery history in lower limbs * acute low back pain * having a neurological disease * having sensory deficists * the ones with rheumatological diseases which can cause low back pain * being pregnant * having a disc hernia pressuring to sacral nerves
impact of bariatric surgery on epicardial adipose tissue and on myocardial function

Conditions: Severely Obese Patients

Summary: growing evidence suggests that bariatric surgery is a relevant treatment for severely obese patients, especially those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. its action on adipose tissue distribution and in particular on epicardial adipose tissue eat remains unknown. whether metabolic improvement is associated with eat reduction is also unknown. the researchers thus investigated the effect of bariatric surgery on eat in severely obese patients. the primary endpoint of this study was the change in eat amount 6 months after bariatric surgery.

the best of our knowledge, no study has really addressed whether this eat was modulated by diet or therapeutics like bariatric surgery. the researchers were particularly interested in studying the impact of bariatric surgery and of weight loss on the amount of eat and whether reduction in eat could have a positive impact on myocardial function.

Eligibility criteria:
inclusion criteria: * men or women who have more than 18 years * patients have been informed and have consented * severely obese patients with surgery indication exclusion criteria: * contraindications at surgery, at mnr imagery * history of infarct, of congenital cardiomyopathy * treatment modifying the distribution of the fat * pregnant or breast-feeding women * patients less than 18 years * patient without consentment

Keywords: severely obese patients
icg angiogram as a predictor of postoperative visual function after eea surgery

Conditions: Indocyanine Green; Skull Base Neoplasms

Summary: endonasal endoscopic approaches are an established treatment for suprasellar lesions compromising the optic nerves (on). surgery often involves dissecting tumors from the optic nerves and its blood supply, which can result in nerve damage and visual loss after surgery. to date, there are no reliable methods to monitor the optic nerve function during surgery and thus, post-surgical visual outcomes is unknown until the patients are fully awake after surgery for a visual exam. this delay in diagnosis prevents early therapeutic measures and can result in further harm to the on. we have recently recognized that when icg is routinely injected during these cases to check for patency of the big arteries the sub millimetric superior hypophyseal arteries supplying (sha) the on are also visible and that lack of visualization of these vessels is associated with worse visual deficits after surgery. thus, icg may be a tool to intraoperative predict visual outcomes after endonasal approach for suprasellar lesions and fill the nondiagnostic gap. this study will assess whether endoscopic icg angiography before and after resection of suprasellar lesions can predict post-operative visual deficits. successful completion will provide surgeons a novel tool to assess visual function during surgery. the icg endoscopic angiograms suggested in this study are noninvasive and currently routinely performed at the end of surgery to check for patency of big brain arteries.


Eligibility criteria:
inclusion criteria: * the study will enroll adult (18 y.o. and older) participants undergoing endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas. exclusion criteria: * underage patients (younger than 18 y.o).
air versus oxygen for intermediate-risk pulmonary embolism (aire)

Conditions: Pulmonary Embolism

Summary: the primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with intermediate-risk pulmonary embolism. the secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with intermediate-risk pulmonary embolism.


Eligibility criteria:
inclusion criteria: * confirmed pe by multidetector computed tomographic pulmonary angiography (mdct). * disfunction of right ventricle (rv to left ventricle \[lv\] diameter ratio \>1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after pe diagnosis. * signed and dated informed consent of the subject. exclusion criteria: * \<18 years old. * allergy to iodinated contrast. * renal failure defined as a creatinine clearance less than 30 ml/min, according to the cockcroft-gault formula. * use of chronic oxygen therapy. * hypercapnia (pco2 \>50 mmhg at the time of diagnosis). * technically inadequate basal echocardiography. * contraindication to anticoagulant therapy. * symptoms duration \>10 days. * haemodynamic instability. * participation in other clinical trial for pe treatment during the present clinical trial. * inability to use mask or nasal prongs. * life expectancy less than 90 days.
a study of inclisiran in participants with renal impairment compared to participants with normal renal function (orion-7)

Conditions: Renal Impairment

Summary: this study is a phase i, single-dose, open-label trial to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics of a single dose of inclisiran subcutaneous (sc) injection in participants with mild, moderate, and severe renal impairment compared to participants with normal renal function.


Eligibility criteria:
inclusion criteria: * male and female participants 18 to 80 years of age * participants should be qualified for inclusion based upon estimated crcl ranges for normal renal function group and mild, moderate, and severe renal impairment groups exclusion criteria: * participants with acute renal disease and/or history of renal transplant * urinary incontinence without catheterization * participants requiring hemodialysis * participants with ldl-c \<60 mg/deciliter (dl) (or less than 1.55 millimoles/liter \[mmol/l\]) * participants with amyloid kidney (if known by pathology) * participants with any significant hepatic, cardiac, or pulmonary disease or participants who are clinically nephritic the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.